IFEX Powder for solution for injection (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Baxter Healthcare Corporation

Λέξεις κλειδιά

0338-3991 0338-3993

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1. Indications and Usage

IFEX is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis ...

2. Dosage and Administration

IFEX should be administered intravenously at a dose of 1.2 grams per m² per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity. In order to prevent ...

3. Dosage Forms and Strengths

1 gram single-dose vial. 3 gram single-dose vial.

4. Contraindications

IFEX is contraindicated in patients with: Known hypersensitivity to administration of ifosfamide. Urinary outflow obstruction.

5. Warnings and Precautions

5.1 Myelosuppression, Immunosuppression, and Infections Treatment with ifosfamide may cause myelosuppression and significant suppression of immune responses, which can lead to severe infections. Fatal ...

6.1. Clinical Trials Experience

Because clinical trials are conducted from widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of IFEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

Ifosfamide is a substrate for both CYP3A4 and CYP2B6. 7.1 Inducers of CYP3A4 CYP3A4 inducers (e.g., carbamazepine, phenytoin, fosphenytoin, phenobarbital, rifampin, St. John Wort) may increase the metabolism ...

8.1. Pregnancy

IFEX can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide‑containing chemotherapy regimens during ...

8.3. Nursing Mothers

Ifosfamide is excreted in breast milk. Because of the potential for serious adverse events and the tumorigenicity shown for ifosfamide in animal studies, a decision should be made whether to discontinue ...

8.4. Pediatric Use

Safety and effectiveness have not been established in pediatric patients.

8.5. Geriatric Use

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. ...

8.6. Renal Impairment

No formal studies were conducted in patients with renal impairment. Ifosfamide and its metabolites are known to be excreted by the kidneys and may accumulate in plasma with decreased renal function. Patients ...

8.7. Hepatic Impairment

No formal studies were conducted in patients with hepatic impairment. Ifosfamide is extensively metabolized in the liver and forms both efficacious and toxic metabolites. IFEX should be given cautiously ...

10. Overdosage

No specific antidote for IFEX is known. Patients who receive an overdose should be closely monitored for the development of toxicities. Serious consequences of overdosage include manifestations of dose-dependent ...

11. Description

IFEX (ifosfamide for injection, USP) single-dose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Ifosfamide is a chemotherapeutic ...

12.1. Mechanism of Action

Ifosfamide is a prodrug that requires metabolic activation by hepatic cytochrome P450 isoenzymes to exert its cytotoxic activity. Activation occurs by hydroxylation at the ring carbon atom forming the ...

12.3. Pharmacokinetics

Ifosfamide exhibits dose-dependent pharmacokinetics in humans. At single doses of 3.8 to 5.0 g/m², the plasma concentrations decay biphasically and the mean terminal elimination half-life is about 15 hours. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Ifosfamide has been shown to be carcinogenic in rats when administered by intraperitoneal injection at 6 mg/kg (37 mg/m², or about 3% of the daily human dose on a mg/m² basis) 3 times a week for 52 weeks. ...

14. Clinical Studies

Patients with refractory testicular cancer (n=59) received a combination of ifosfamide, cisplatin, and either etoposide (VePesid) or vinblastine (VIP) as third-line therapy or later. The selection of etoposide ...

15. References

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers ...

16.1. How Supplied

IFEX (ifosfamide for injection, USP) is available in single-dose vials as follows: IFEX (ifosfamide for injection) NDC 0338-3991-01 1-gram Single-Dose Vial NDC 0338-3993-01 3-gram Single-Dose Vial Manufactured ...

16.2. Storage and Handling

Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from temperatures above 30°C (86°F). Exercise caution when handling IFEX. The handling and preparation of ifosfamide should always ...

17. Patient Counseling Information

Myelosuppression, Immunosuppression, and Infections: Advise patients that treatment with IFEX may cause myelosuppression which can be severe and lead to infections and fatal outcomes. Inform patients ...

BOXED WARNING SECTION

WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. ...